54928 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104-113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a FIFRA 

section 18 exemption under section 408 

of the FFDCA, such as the tolerance in 

this final rule, do not require the 

issuance of a proposed rule, the 

requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 8, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—AMENDED 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.620 is added to read as 

follows: 

§ 180.620 Etofenprox; tolerances for 

residues. 

(a) General. [Reserved] 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of etofenprox (2- 

[ethoxyphenyl]-2-methylpropyl-3- 

phenoxy benzyl ether) in connection 

with use of the pesticide under section 

18 emergency exemptions granted by 

EPA. The tolerances will expire and are 

revoked on the dates specified in the 

following table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Rice, grain ........ 0.01 12/31/09 

Rice, straw ........ 0.02 12/31/09 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 06–8004 Filed 9–19–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0617; FRL–8091–6] 

Pantoea Agglomerans Strain E325; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Pantoea 

agglomerans strain E325 on apples and 

pears when applied/used as a microbial 

pesticide. Northwest Agricultural 

Products submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Pantoea agglomerans 

strain E325. 

DATES: This regulation is effective 

September 20, 2006. Objections and 

requests for hearings must be received 

on or before November 20, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 


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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54929 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0617. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Leonard Cole, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5412; e-mail address: 

cole.leonard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Document Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this ‘‘Federal Register’’ document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0617 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 20, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0617, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of July 26, 

2006 (71 FR 42395) (FRL–8080–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 6F7086) 

by Northwest Agricultural Products, 821 

South Chestnut Ave., Pasco, 

Washington 99301. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Pantoea agglomerans strain 

E325. This notice included a summary 

of the petition prepared by the 

petitioner Northwest Agricultural 

Products. There were no comments 

received in response to the notice of 

filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue.... ’’

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 


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exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Pantoea agglomerans strain E325 was 

originally isolated from apple blooms in 

Wenatchee, Washington. Pantoea 

agglomerans strain E325 was isolated 

from an apple flower stigma by washing 

the flower in buffer and plating 

dilutions on agar media. The Microbial 

Pest Control Agent (MPCA) was selected 

from among more than 1,000 bacteria 

and yeast isolates evaluated for 

potential use in the control of fire blight. 

Screening assays were based on the 

ability of test organisms to colonize the 

stigma and preemptively exclude the 

disease organism which was introduced 

24 hours after treatment with the test 

organism. 

Pantoea agglomerans is ubiquitous in 

the environment, and is recognized as 

an epiphyte of a wide variety of plants, 

such as buckwheat, weeds, oilseed rape, 

sweet potato, rice, and trees of the 

Rosaceae family. Pantoea agglomerans 

is found on a wide variety of plant parts, 

including the rhizosphere, leaves, and 

seeds. The species is also a heavy 

colonizer of cotton plants, grass and 

silage and is the prominent species in 

organic dust. The organism has also 

been isolated from soil and water. 

Recent reports have also identified P. 

agglomerans on retail salad vegetables. 

Pantoea agglomerans is a common 

organism of the gut microbiota of 

mosquitos and locusts. In fecal pellets of 

the locust, the organism is responsible 

for the release of guaiacol and phenol, 

essential components of the locust 

cohesion pheromone. These 

components are not produced in germfree locusts. Pantoea agglomerans 

(Enterobacter agglomerans) was also 

identified in association with sheep 

scab mites, and as an intracellular 

symbiotic bacteria of the cereal weevil 

and the apple maggot fly. It has been 

demonstrated that Enterobacter 

agglomerans (in the gut of the fly) is 

able to detoxify the defense chemical 

(phloridzin) of the apple tree, which 

would otherwise kill the fly. 

Fire blight is caused by the 

phytopathogenic bacterium Erwinia 

amylovora which colonizes 

predominately on the stigmatic surfaces 

of the apple or pear. The pathogen may 

enter the tree through the blossoms, 

leaves, or stem wounds. Usually the 

disease is spread by bacteria that over 

winter in holdover cankers in the main 

stem and branches or infected twigs. In 

the spring, when the blossoms begin to 

open, the cankers exude drops of 

bacterial ooze that are disseminated to 

the blossoms and young leaves by rain, 

heavy dew, or windblown mist. Fire 

blight may also be spread by pollinating 

insects such as bees, sucking, chewing, 

or boring insects, and unsanitary 

pruning tools. Warm temperatures (24–

28°C) and high humidity are the optimal 

conditions for infection and disease 

development. 

The disease becomes apparent in the 

spring, when infected blossoms 

suddenly wilt and turn brown. Later, 

twigs and leaves also turn brown and 

appear to be scorched by fire. The 

affected leaves usually remain on the 

tree well into the winter. Young infected 

fruits become watery or oily in 

appearance and exude droplets of clear, 

milky, or amber colored ooze. They later 

become leathery and turn brown, dark 

brown, or black, depending on the 

species. The shriveled fruit usually 

remains attached to the tree. 

Fire blight is considered one of the 

most destructive diseases of fruit trees 

in North America. It occurs sporadically 

and unpredictably and occasionally 

reaches epidemic levels. A severe 

outbreak can seriously damage or kill 

mature pear, apple, or crab apple trees 

in one season. Other ornamentals such 

as hawthorn, plum, chokecherry, 

saskatoon, cotoneaster, and spirea may 

also be affected. 

1. Acute oral toxicity/pathogenicity—

rats (OPPTS 885.3050). Nineteen male 

and 19 female Sprague-Dawley rats were 

dosed with the test substance, Pantoea 

agglomerans strain E325, at a rate of 

1.05 x 108 colony forming unit (CFU) 

per animal. (Master Record 

Identification Number (MRID) 464678–

02) (Ref 1). Three animals were 

sacrificed on day 3, 7, and 14. All rats 

survived to the scheduled sacrifice. 

There was no change in organ weights 

(brain, blood, cecum contents, kidneys, 

liver, lungs, lymph nodes, and spleen) 

of male and female test animals from 

beginning of testing to sacrifice. The 

MPCA was detected at high levels in the 

organs of all test animals. Clearance of 

the MPCA from the blood and lymph 

node was achieved in all test animals. 

Counts of the MPCA had fallen in the 

lungs and kidney of test animals by day 

7. Results from day 14 showed that the 

MPCA was cleared from all organs in all 

test animals. No clinical manifestations 

of treatment were noted. Gross necropsy 

revealed no indications of treatmentrelated pathology or any unusual 

findings. It is concluded that Pantoea 

agglomerans strain E325 is not acutely 

toxic to rats following oral 

administration. 

2. Acute pulmonary toxicity/ 

pathogenicity—rat (OPPTS 885.3150). 

Forty-eight male and 48 female SpragueDawley rats were dosed with the test 

substance, Pantoea agglomerans strain 

E325 at a rate of 1.8 x 1011 CFU per 

animal. (MRID 464678–03) Ref 2. The 

test material was determined to be 

below 100 CFU per animal at all time 

points tested. The test organism 

(Pantoea agglomerans strain E325) was 

cleared from the cecum contents by day 

7 and from the lungs by day 14. The 

MPCA was detected in the kidney and 

lymph nodes, spleen, and brain up to 

day 14, but had cleared in all animals 

by day 21. Therefore, based on the 

presented/submitted data, the test 

organism was not toxic nor pathogenic 

to the test animals. 

3. Acute dermal toxicity—rabbits 

(OPPTS 870.2500 and OPPTS 

885.3100). The registrant has requested 

that the dermal irritation study be 

waived. Pantoea agglomerans is found 

on a wide variety of plant parts, 

including the rhizosphere, leaves, and 

seeds. The species is also a heavy 

colonizer of cotton plants, grass, and 

silage, and is the prominent species in 

organic dust. The organism has also 

been isolated from soil and water. 

Recent reports have also identified P. 

agglomerans on retail salad vegetables. 

There have been no adverse dermal 

effects or dermal irritation reported in 

any cited literature for Pantoea 

agglomerans strain E325. In light of the 

strong evidence indicating no adverse 

effects due to dermal exposure to 

Pantoea agglomerans, EPA has agreed to 

waive dermal toxicity testing. Further, 

data show that exposure from ambient 

populations is sufficiently high that it 

indicates there would be no adverse 

dermal effects from pesticidal use no 

matter what the residue level is. 

4. Primary eye irritation (OPPTS 

870.2400). The registrant has requested 

a waiver for the primary eye irritation 

study. Due to the fact that Pantoea 

agglomerans is found in food and 

drinking water, and there have been no 

adverse eye irritation effects reported, 

Pantoea agglomerans is not considered 

to be an eye irritant. Additionally 

Pantoea agglomerans is ubiquitous in 

the environment, and it is recognized as 

an epiphyte of a wide variety of plants 

such as sweet potato, rice, and organic 


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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54931 

dust. No reports of eye irritation have 

been reported for this organism. 

5. Data waiver requests. Data waiver 

requests were made for the following 

requirements for the Technical Grade of 

the Active Ingredient/Manufacturinguse Product (TGAI/MP) and 

Experimental Product (EP): 

• Acute Intravenous (IV), 

Intracerebral (IC), Intraperitoneal (IP) 

injection Toxicity/Pathogenicity 

(OPPTS 885.3200). 

• Cell Culture (OPPTS 885.3500). 

• Immune Response (OPPTS 

880.3800). 

• Hypersensitivity study. 

• Hypersensitivity Incidents (OPPTS 

885.3400). 

i. Acute inhalation toxicity/ 

pathogenicity. The registrant cited the 

acute pulmonary toxicity/pathogenicity 

study (see Unit III.?.3.) to justify waiving 

the acute inhalation study. In the acute 

pulmonary toxicity/pathogenicity study 

Pantoea agglomerans strain E325, was 

not found in any organs or tissues 

which indicates that the active 

ingredient cleared tissues and was not 

toxic, infective, or pathogenic to rats 

when instilled intratracheally. 

Additionally, when this product is 

applied, applicators will be required to 

wear the necessary protective 

equipment to prevent inhalation, and 

this justifies granting this request to 

waive acute-inhalation data 

requirements. 

ii. Acute IV/IP/IC study. In an acute 

oral toxicity/pathogenicity study (see 

Unit III.1. and 2.), no clinical signs of 

toxicity were observed in rats and no 

Pantoea agglomerans strain E325 was 

recovered from organs or tissues. These 

data show that Pantoea agglomerans 

strain E325 was considered to clear 

rapidly from the test animal in that it 

was never detected. The active 

ingredient Pantoea agglomerans strain 

E325 is considered to be non-toxic. 

Based on the low toxicity potential 

indicated by these observations, the 

request to waive the acute IP study was 

granted. 

iii. Cell culture. This study is required 

for a virus and is not required for a 

bacterial active ingredient such as 

Pantoea agglomerans strain E325. 

iv. Immune response. The lack of 

pathogenicity seen in the acute oral 

toxicity/pathogenicity study with the 

active ingredient indicates the immune 

system was not adversely affected by 

Pantoea agglomerans strain E325. Based 

on these considerations, the 

justifications to support the request to 

waive data requirements for the immune 

response studies for the TGAI/MP are 

acceptable. 

v. Hypersensitivity study. No 

incidents of hypersensitivity have 

occurred during the research, 

development, or testing of Pantoea 

agglomerans strain E325 or the end use 

product, Bloomtime. A hypersensitivity 

study is not required at this time, but 

may be required in the future if there are 

reports of hypersensitivity incidents 

associated with this active ingredient 

used in pesticides. If a person is 

abnormally physiologically susceptible 

to a specific agent, there are a number 

of symptoms that the individual will 

exhibit. This organism has been in 

nature for many years, and there have 

been no reports of any human or animal 

exhibiting any symptoms after having 

been in contact with the organism. 

vi. Hypersensitivity incidents (OPPTS 

885.3400). The registrant requested to 

waive reports of hypersensitivity 

incidents, because no incidents of 

hypersensitivity associated with the 

TGAI or the EP have been reported. 

However, the registrant agreed to report 

hypersensitivity incidents, should they 

occur in the future. This guideline 

requirement is satisfied at this time. In 

order to comply with the Federal 

Insecticide, Fungicide, and Rotenticide 

Act (FIFRA) requirements under section 

6(a)(2), any incident of hypersensitivity 

associated with the use of this pesticide 

must be reported to the Agency. This 

data requirement has not been waived. 

6. Subchronic, chronic toxicity and 

oncogenicity, and residue data. Based 

on the data generated in accordance 

with the Tier I data requirements set 

forth in 40 CFR 158.740(c), the Tier II 

and Tier III data requirements were not 

triggered and, therefore, not required in 

connection with this action. In addition, 

because the Tier II and Tier III data 

requirements were not required, the 

residue data requirements set forth in 40 

CFR 158.740(b) also were not required. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Use of Pantoea agglomerans strain 

E325 is not expected to cause any harm 

via consumption of food or feed treated 

with the microbial pesticide, which is 

not applied directly to food as discussed 

in this unit. 

1. Food. Residues of Pantoea 

agglomerans strain E325 are not 

expected on treated food commodities 

from the proposed use patterns. The 

product, Bloomtime, containing Pantoea 

agglomerans strain E325, is applied at 

bloom followed by a second application 

at first petal fall-full bloom. After 

Bloomtime is applied, the pesticide 

becomes non-viable very rapidly, which 

causes the need for more than one 

application. The pesticide itself is not in 

direct contact with the food 

commodities. This pesticide is applied 

prior to fruiting. There is no postharvest treatment directly to the food 

commodities. Furthermore, the active 

ingredient is not a systemic pesticide. 

Thus, detectable residues of Pantoea 

agglomerans strain E325 are not 

expected on treated fruit trees or their 

food commodities. Furthermore, as 

previously stated, Pantoea agglomerans 

strain E325 is found in soil, water, and 

air. Data submissions to the Agency 

show that residues of the Pantoea 

agglomerans strain E325 are not found 

on the food commodities. Finally, as 

discussed previously in Unit III., the 

acute oral tests demonstrate low toxicity 

potential via dietary exposure to this 

Toxicity Category IV pesticide. Hence, 

even if the pesticide was present in or 

on food commodities, exposure via the 

dietary route is not expected to cause 

any harm. Therefore, the Agency has 

decided that dietary exposure from the 

proposed uses of Pantoea agglomerans 

strain E325 is not expected to adversely 

affect the U.S. adult population, infants, 

and children. 

2. Drinking water exposure. No 

drinking water exposure is anticipated 

because of the use pattern and use sites. 

There are no aquatic use sites permitted 

for this pesticide, so exposure to 

drinking water is not expected. Further, 

there is no evidence of adverse effects 

from exposure to this organism. 

Exposure from the proposed use of 

Pantoea agglomerans strain E325 is not 

likely to pose any incremental risk via 

consumption of drinking water to adult 

humans, infants and children. 

B. Other Non-Occupational Exposure 

The proposed product is an end-use 

product to be commercially used in 

apple and pear orchards. No nonoccupational residential, school or day 

care exposure is anticipated because of 

the use pattern of this product. The use 

of Panteoa agglomerans strain E325 

should result in minimal to nonexistent, non-occupational risk. No 

indoor residential, school, or daycare 

uses are permitted on the label of this 

product. 


rwilkins on PROD1PC63 with RULES
54932 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

1. Dermal exposure. The low toxicity 

potential observed in the acute dermal 

studies discussed in Unit III., the low 

exposure potential based on low 

application rates, and the lack of 

persistence of the active ingredient, 

leads EPA to conclude that this 

pesticide poses minimal risk to human 

populations via non-occupational 

dermal exposure. Moreover, potential 

non-occupational dermal exposure to 

Panteoa agglomerans strain E325 is 

unlikely because the use sites are 

commercial and agricultural. 

As previously discussed in Units III. 

and IV., a lack of hypersensitivity 

incidents indicates Panteoa 

agglomerans strain E325 poses minimal 

risk to populations via non-occupational 

dermal exposure. Thus, the Agency does 

not expect pesticides containing 

Panteoa agglomerans strain E325 to 

pose a non-occupational dermal 

exposure risk. 

2. Inhalation exposure. Nonoccupational inhalation exposure to the 

active ingredient itself is not expected to 

pose an inhalation risk. No treatmentrelated effects associated with the active 

ingredient were observed in the 

pulmonary tests reported in Unit II. 

Based on the low potential for nonoccupational inhalation exposure, the 

Agency does not expect Pantoea 

agglomerans strain E325 to pose an 

inhalation risk. 

V. Cumulative Effects 

The Agency has considered the 

potential for cumulative effects of 

Pantoea agglomerans strain E325 and 

other substances in relation to a 

common mechanism of toxicity. These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. As demonstrated 

in the toxicity assessment, Pantoea 

agglomerans strain E325 is non-toxic 

and non-pathogenic to mammals. 

Because no mechanism of pathogenicity 

or toxicity in mammals has been 

identified for this organism, no 

cumulative effects from the residues of 

this product with other related 

microbial pesticides are anticipated. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

There is reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposures to residues of 

Pantoea agglomerans strain E325, as a 

result of its proposed uses. This 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. As 

discussed previously, there appears to 

be no potential for harm, from this 

bacterium in its use as a microbial 

pesticide in apple and pear orchards. 

Furthermore, the organism is non-toxic 

and non-pathogenic to animals and 

humans. The Agency has arrived at this 

conclusion based on the very-low levels 

of mammalian toxicity for acute oral, 

pulmonary, and dermal effects with no 

toxicity or infectivity at the doses tested 

(see Unit III.). Moreover, potential nonoccupational inhalation or dermal 

exposure is not expected to pose any 

adverse effects to exposed populations 

via aggregate and cumulative exposure. 

VII. Other Considerations 

A. Endocrine Disruptors 

EPA is required under section 408(p) 

of FFDCA, as amended by FQPA, to 

develop a screening program to 

determine whether certain substances 

(including all pesticide active and other 

ingredients) ‘‘may have an effect in 

humans that is similar to an effect 

produced by a naturally-occurring 

estrogen, or other such endocrine effects 

as the Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there was 

scientific basis for including, as part of 

the program, the androgen and thyroid 

systems, in addition to the estrogen 

hormone system. EPA also adopted 

EDSTAC’s recommendation that the 

program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority, to require 

the wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). The Agency 

is not requiring information on the 

endocrine effects of this active 

ingredient at this time. The Agency has 

considered, among other relevant 

factors, available information 

concerning whether the microorganism 

may have an effect in humans similar to 

an effect produced by a naturallyoccurring estrogen or other endocrine 

effects. 

There is no known metabolite 

produced by this bacterium that acts as 

an endocrine disruptor. The submitted 

and cited toxicity/pathogenicity studies 

in rodents indicate that following 

injection and pulmonary routes of 

exposure, no test substance was found 

in organs or tissues of test animals. This 

indicates that the body is able to process 

and clear the active ingredient. The 

Agency concludes that there will be no 

incremental adverse effects to the 

endocrine system. 

B. Analytical Methods 

The acute oral studies discussed in 

Unit II. demonstrate that the active 

ingredient, Pantoea agglomerans strain 

E325 does not pose a dietary risk. In 

addition, the active ingredient is not 

likely to come into contact with food 

commodities. Since residues are not 

expected on treated commodities, the 

Agency has concluded that an analytical 

method to detect residues of this 

pesticide on treated food commodities 

for enforcement purposes is not needed. 

Nevertheless, the Agency has concluded 

that for analysis of the pesticide itself, 

microbiological and biochemical 

methods exist and are acceptable for 

enforcement purposes for product 

identity of Pantoea agglomerans strain 

E325. Other appropriate methods are 

required for quality control to assure 

that product characterization, the 

control of human pathogens and other 

unintentional metabolites or ingredients 

are within regulatory limits, and to 

ascertain storage stability and viability 

of the pesticidal active ingredient. 

C. CODEX Maximum Residue Level 

There is no CODEX maximum residue 

level for residues of Pantoea 

agglomerans strain E325. 

VIII. Conclusions 

The results of the studies discussed in 

Unit II. are sufficient to comply with the 

requirements of FQPA. They support an 

exemption from the requirement of a 

tolerance for residues of Pantoea 

agglomerans strain E325 on apples and 

pears. In addition, the Agency is of the 

opinion that, if the microbial active 

ingredient is used as labeled, aggregate 

and cumulative exposures are not likely 

to pose any undue risk. Submitted and 

cited data show that Pantoea 

agglomerans strain E325 do not pose an 

incremental dietary and non-dietary risk 

to the adult human U.S. population, 

children, and infants. Therefore, an 

exemption from tolerance is granted in 

response to pesticide petition 6F7087. 

MRID Citation References 

1. 464678–02, Kuhn, J.O., Acute Oral 

Toxicity/Pathogenicity Study in Rats 

With A Microbial Pest Control Agent 

(MPCA). 

2. 464678–03, Kuhn, J.O., Acute 

Pulmonary Toxicity/Pathogenicity 

Study In Rats With A Microbial Pest 

Control Agent (MPCA). 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54933 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the exemption from the requirement of 

a tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

X. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 11, 2006. 

James J. Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.1272 is added to 

subpart D to read as follows: 

§ 180.1272 Pantoea agglomerans strain 

E325; exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pantoea agglomerans strain E325 

when used on apples and pears. 

[FR Doc. 06–8005 Filed 9–19–06; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[FEMA Docket No. D–7642] 

Withdrawal of Final Flood Elevation 

Determination for the Listed 

Communities in Yuma and Coconino 

Counties, AZ 

AGENCY: Federal Emergency 

Management Agency (FEMA), 

Department of Homeland Security 

(DHS). 

ACTION: Final rule; withdrawal. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) withdraws 

the final flood elevation determination 

published in 71 FR 33647, June 12, 2006 

for the Unincorporated Areas of Yuma 

County and Cities of San Luis and 

Yuma, and the Unincorporated Areas of 

Coconino County, and City of Flagstaff, 

Arizona, hereafter referred to as ‘‘listed 

communities.’’ A final flood elevation 

determination will be made at a later 

date. 


rwilkins on PROD1PC63 with RULES